Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy

Abstract

IMPORTANCE Although PCSK9 inhibitors (PCSK9i) were approved in 2015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK9i in clinical practice has been low. OBJECTIVE To evaluate patient access to PCSK9i among those prescribed therapy. DESIGN, SETTING, AND PARTICIPANTS Using pharmacy transaction data, we evaluated 45,029 patients newly prescribed PCSK9i in the United States between 08/01/2015 and 07/31/2016. MAIN OUTCOMES AND MEASURES Main outcomes were: the proportion of PCSK9i prescriptions approved and abandoned (approved but unfilled); multivariable analyses examined factors associated with approval/abandomnent including payor, prescriber specialty, pharmacy benefit manager (PBM), out-of-pocket cost (copay), clinical diagnoses, lipid lowering medication use, and low density lipoprotein cholesterol (LDL-C) levels. RESULTS Of patients given an incident PCSK9i prescription, 20.8% received approval on the first day, and 47.2% ever received approval. Of those approved, 65.3% filled the prescription, resulting in 30.9% of those prescribed PCSK9i ever receiving therapy. After adjustment, patients who were older, male and had ASCVD were more likely to be approved, but approval rates did not vary by patient low density lipoprotein (LDL-C) level nor statin use. Other factors associated with drug approval included: having government versus commercial insurance (odds ratio [OR] 3.3, 95% confidence interval [CI] 2.8–3.8), and those filled at a specialty versus retail pharmacy (OR 1.96, 95% CI 1.66–2.33). Approval rates varied nearly 3-fold among the top 10 largest PBMs. Prescription abandonment by patients was most associated with copay costs (c-statistic 0.86); with abandonment rates ranging from 7.5% for those with $0 copay, to more than 75% for copays greater than $350. Limitations include that the analysis was conducted in the first year of availability before outcomes trials results. CONCLUSIONS AND RELEVANCE In the first year of availability, only half of patients prescribed a PCSK9 received approval, and one third of approved prescriptions were never filled due to copay.

Application of PCSK9 Inhibitors in Practice

“…This high approval rate and low patient out-of-pocket expenditure stands in contrast with media reports and the peer-reviewed literature in which about a third of patients were reported never filling PCSK9i prescriptions primarily due to cost. 10 Moreover, within our model, we noted dramatic improvements in time from initial visit to drug approval and time from initial visit to first injection, with median times of 44 days and 64.5 days prior to implementation of our program, dropping to current times of 15 days and 17 days, respectively. While this enhanced efficiency was partially due to the addition of dedicated personnel, it was largely accounted for by the adoption of a formalized and standardized evaluation process that ensured proper documentation of insurance criteria for coverage, transitioning from a paper to electronic format for insurance application, and, with time, improved understanding and communication with insurance companies in response to denials.…”

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

“…[12][13][14][15] Claims-based analyses have reported that only ≈20% of PCSK9i prescriptions were initially approved, with ultimate approval rates of 43% to 47% after additional attempts. 13,14 A recent study reported that only 37% to 42% of submitted PCSK9i prescriptions were ultimately approved for FH and ASCVD patients with LDL-C >190 and 100 mg/dL, respectively, despite evidence of use of appropriate lipid-lowering therapy-and approval took >2 months for 40% of these prescriptions. 15 That is, even in patients who should have met medical necessity criteria, rejection rates were high and approvals were often slow.…”

“…Although PA is a common utilization management strategy, 7 early anecdotal reports have indicated that the PA process for PCSK9is has been particularly challenging for providers [8][9][10][11] and that rejection rates for submitted PCSK9i prescriptions have been high, including for patients with evidence of medical necessity. [12][13][14][15] Potential administrative barriers to treatment are of particular concern for patients with FH or uncontrolled ASCVD, who are at high risk of cardiovascular events. Thus, more comprehensive data on potential PA-related access barriers for PCSK9is are needed.…”

Elephant in the Room

“…A high-burden PA process may be related to high rates of rejection for submitted PCSK9i prescriptions because other studies have reported that commercial payers also had the lowest PA approval rates. 2,3 Why are we examining the intricate details of the PCSK9i PA process and high rejection rates? The reason is clear-simply put, these drugs are expensive and at a level not previously seen for a drug with this potentially large of a market.…”

“…In evaluations of current populations that might be eligible for PCSK9i, more than half of eligible patients were not receiving statin therapy, which clearly represents a deficiency in optimal risk reduction management. 2,3 Oftentimes, excitement surrounding the uptake of new drugs drives potential overuse, even in the absence of outcomes evidence, with subsequent difficulty with reining in prescribing in all but the strictest of formularies. 8 Abandonment of existing effective therapies may also ensue, and this seems to be the case with the excitement surrounding PCSK9i.…”